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Infection and Malignancy Risk in Patients Treated with TNF Inhibitors for Immune-Mediated Inflammatory Diseases

[ Vol. 12 , Issue. 3 ]


Rui Pereira, Raquel Faria, Paula Lago and Tiago Torres*   Pages 162 - 170 ( 9 )


Background: Infectious and malignant events are responsible for morbidity and mortality in patients with Immune-Mediated Inflammatory Diseases (IMIDs). Anti-tumor necrosis factor (Anti-TNF) agents appear to have an impact, however the individual effect of these agents in the different conditions is still unclear.

Objective: The aim of this study is to estimate the Incidence Rates (IR) of infections and malignancies in patients treated with anti-TNFs across different IMIDs, as well as potential risk factors. Methods: IR/100 patient-years were evaluated in adult patients treated for any IMID with an anti-TNF between January 2000 and December 2014. Predictors were tested with bivariate and multivariate statistical analysis.

Results: The IR/100 patient-years of serious infections was 4.02 (95% CI 3.20-5.04) with significant differences across IMIDs and anti-TNF agents. The most frequent site of serious infection was the gastrointestinal system. Five cases [IR of 0.28 (95% CI 0.12-0.66) /100 patient-years] of tuberculosis were diagnosed, exclusively in patients treated with monoclonal antibodies. Three (60%) of those were extrapulmonary. The IR/100 patient-years of malignancy was 1.75 (95% CI 1.24-2-47).

Conclusion: There is significant variability in the IR of infections across indications and agents. Thus, physicians should be thoughtful when generalizing data from literature regarding the use of an anti-TNF agent in a specific IMID. Further studies are necessary to clear aspects regarding the safety of individual anti-TNF biologics and to clarify their impact in the different IMIDs.


Immune-mediated inflammatory diseases, infection, inflammatory bowel disease, malignancy, psoriasis, rheumathoid arthritis, spondyloarthropathies, TNF inhibitors.


Instituto de Ciencias Biomedicas Abel Salazar, University of Porto, Porto, Instituto de Ciencias Biomedicas Abel Salazar, University of Porto, Porto, Instituto de Ciencias Biomedicas Abel Salazar, University of Porto, Porto, Department of Dermatology, Rua D. Manuel II, s/n, Servico de Dermatologia Centro Hospitalar do Porto, piso 1 4050-344 Porto

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